Recruiting
Phase 1

Synthetic Nicotine

Sponsor:

UCLA

Code:

NCT05962229

Conditions

Nicotine Dependence

Nicotine Vaping

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

(S)-Nicotine

(R)- nicotine

Racemic nicotine

Study Details

Brief summary:

In a crossover study, experienced electronic cigarette users will vape 3 different forms of nicotine: natural (derived from tobacco), synthetic, or a 50:50 mixture of both natural and synthetic. The investigators will compare nicotine metabolism, cardiovascular effects, patterns of self-administration, and participants' feelings of craving/withdrawal and enjoyment.

Conditions

Nicotine Dependence

Nicotine Vaping

Study ID

NCT05962229

Start date

Dec 6, 2024

Status verified date

Dec, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy on the basis of medical history and limited physical examination.
  • Current regular user of E-Cigarettes (≥ 15 days in the past 30 days)

Exclusion Criteria:

  • • Medications

  • Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
  • Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers).
  • Concurrent use of nicotine-containing medications (Example: nicotine patch, lozenge, gum).
  • Any stimulant medications (example: Adderall) generally given for ADHD treatment.

• Pregnancy
  • Pregnancy (self-reported and urine pregnancy test)
  • Breastfeeding (determined by self-report)
  • Women of childbearing potential must be using an acceptable method of contraception

  • Inability to read and write in English
  • A known propylene glycol/vegetable glycerin allergy
  • Uncomfortable with getting blood drawn

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: S-nicotine (tobacco) as the starting condition

Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (S)-nicotine.

experimental: R-nicotine (synthetic) as the starting condition

Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 100% (R)-nicotine.

experimental: Racemic (50:50 S- and R- nicotine) as the starting condition

Participants will spend 8 hours in the hospital research ward where they will vape e-liquid containing 50% (S)-nicotine and 50% (R)-nicotine.

Interventions

(S)-Nicotine

Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.

(R)- nicotine

Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 100% (R)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.

Racemic nicotine

Participants will spend 8 hours in the hospital research ward and will vape e-liquid containing 50% (R)-nicotine and 50% (S)-nicotine. They will vape following a standardized session, followed by a 4 hour abstinence period. Participants will then vape as they wish (ad libitum) for 90 minutes.

Primary outcome measure

  • Mean Nicotine Exposure Over Time [ Time Frame: Up to 7 hours ]

Central Contacts and Locations

Central contacts

Lisa Lawrence

628-206-4204lisa.lawrence@ucsf.edu

Armando Barraza

510-560-4842armando.barraza@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital (ZSFG)

Recruiting

San Francisco, California, United States, 94110

Contacts

Lisa Lawrence

415-502-2465lisa.lawrence@ucsf.edu

Armando Barraza

415-502-2465armando.barraza@ucsf.edu

Principal Investigator:

Neal Benowitz, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

May 14, 2026

Last verified

Dec, 2025

Keywords

  • Nicotine Pharmacokinetics
  • Nicotine Pharmacodynamics
  • Vaping
  • E-cigarettes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-14.